Regulatory framework launch event

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Regulatory framework launch event

• Tuesday 25 April 2006

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The Human Tissue Authoritys regulatory
arrangements

• Adrian McNeil
• Chief Executive

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HTAs regulatory arrangements

• The regulatory framework
• The Codes of Practice

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HTAs regulatory remit

• Anatomical examination
• Approve all live transplants
• Storage of tissue
• Pathology services

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New regulator new methods!
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How we are regulating

• Self assessment
• Working with the sectors
• Meshing with other organisations
• Keeping fee levels low
• Providing advice and guidance

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Approving organ donation

• Paired / pooled
• Non-directed altruistic
• What next?

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Codes of Practice

• Consent
• Donation of solid organs
• Post mortem
• Anatomical examination
• Removal / collection / disposal
• Donation of bone marrow

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Any questions?
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The Human Tissue Act and research

• Professor James IronsideProfessor of Clinical
  Neuropathology, University of Edinburgh and HTA
  member

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Medical research and human tissue

• Medical research is essential for the continuing
  improvement in the quality of healthcare in the
  UK
• The public is supportive of medical research and
  donates large sums of money to medical research
  charities
• The use of human tissue in medical research is
  essential for the understanding of disease
  mechanisms, and the prevention, diagnosis and
  treatment of disease
• The HTA recognises the importance of medical
  research and the need to allow this work to
  continue and flourish in the future

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Codes of Practice for research

• Consent
• Removal, storage and disposal of human organs and
  tissue
• Post mortem examination

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Consent

• The HT Act makes consent the fundamental
  principle in the
• storage and use of body parts, organs and tissue
  from the living or deceased for specified
  purposes
• removal of material from the deceased

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Who can give consent?

• Living
• Competent adult or Gillick competent child
• Adults who lack capacity appropriate support to
  be provided
• Child who has not made decision (and is
  non-competent or chooses not to make a decision)
  person with parental responsibility
• Deceased
• Deceaseds wishes
• Nominated representative
• Qualifying relationship hierarchy

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The Human Tissue Act S16

• No person shall do an activity to which
  this section applies otherwise than under the
  authority of a licence granted for the purposes
  of this section.
• 16 (e) the storage of 
• (i) the body of a deceased person, or
• (ii) relevant material which has come from a
  human body,
• for use for a Scheduled Purpose
• Scheduled Purpose in this case is research in
  connection with disorders, or the functioning of,
  the human body

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Who will need a licence?

• Q Do I undertake research on tissue samples
  from living patients?
• Tissue removed and stored for the primary purpose
  of diagnosis or treatment
• No licence
• Tissue removed and stored for the primary purpose
  of research
• Distribution to other researchers (tissue bank)
  licence
• A specific research project with ethical approval
  no licence
• A possible project in the future licence

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Who will need a licence?

• Q Do I undertake research on tissue samples
  from deceased patients?
• Tissue removed and stored to determine the cause
  of death
• Licence required
• Tissue removed and stored for the primary purpose
  of research
• Distribution to other researchers (tissue bank)
  licence
• A specific research project with ethical approval
  no licence
• A possible project in the future licence

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PRIMARY PURPOSEResearch
Is it stored for a specific ethically approved
research project?
No
Yes
Is a licence required?
Is consent required?
Is a licence required?
Is consent required?
Yes, unless material is obtained from a living
person and is anonymised
Yes
Yes
No
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• PRIMARY PURPOSE
• Anatomical examination
• Determining the cause of death
• Establishing after a person's death the efficacy
  of any drug or other treatment administered to
  him
• Obtaining scientific or medical information about
  a living or deceased person which may be relevant
  to any other person (including a future person)
• Public display

Is a licence required?
Is consent required?
No, if material is obtained from a living
person Yes, if material is obtained from a
deceased person
Yes
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• PRIMARY PURPOSE
• Clinical audit
• Education or training relating to human health
• Performance assessment
• Public health monitoring
• Quality assurance

Is a licence required?
Is consent required?
No, if material is obtained from a living
person Yes, if material is obtained from a
deceased person
No, if material is obtained from a living person
Yes, if material is obtained from a deceased
person
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Implications for researchers

• Medical researchers can proceed with their work
  in the knowledge and confidence that consent is
  at the heart of the relevant Codes of Practice
• The proposed licensing system is designed to be
  as unburdensome as possible, supporting existing
  professional standards and allowing further
  development of these standards
• Tissue already stored in archives (existing
  holdings) may be used for future research
  provided the project(s) have the approval of a
  Research Ethics Committee

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Measurement of success

• That the HT Act and the HTAs implementation of
  it, has not placed unnecessary constraints on
  tissue based research.

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Any questions?
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The Human Tissue Act andtransplants

• Keith Rigg
• Consultant Surgeon, Nottingham University
  Hospitals NHS Trust and HTA member

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How does the Human Tissue Act affect organ
donation and transplantation?

• Deceased donor transplantation
• Consent wishes of deceased take precedence
• Lawful to preserve organs for transplantation
  whilst awaiting consent
• Living donor transplantation
• Regulation of all living donor transplantation
• Opportunity for paired / pooled donation and
  non-directed altruistic donation
• Trafficking of human organs remains illegal

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Types of organ donor

• Deceased donor
• Heart beating
• Non heart beating

• Living donor
• Directed genetically and emotionally related
• Domino donor
• Paired / pooled donation
• Non directed altruistic

Also tissue and cell donors
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Types of organ donor

• Deceased donor
• Heart beating
• Non heart beating

• Living donor
• Directed genetically and emotionally related
• Domino donor
• Paired / pooled donation
• Non directed altruistic

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Paired donation
X
Donor A
Recipient A
X
Donor B
Recipient B
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Types of organ donor

• Deceased donor
• Heart beating
• Non heart beating

• Living donor
• Directed genetically and emotionally related
• Domino donor
• Paired/pooled donation
• Non directed altruistic

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What will be the impact on organ donation and
transplantation?1. Deceased donation
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Deceased donation

• Consent is key
• The HT Act makes it clear that where an adult
  has, whilst alive and competent, consented to one
  or more of the Scheduled Purposes taking place
  after their death, then that consent is
  sufficient for the activity to be lawful.
• Wishes expressed by deceased in life paramount
  e.g. ODR but if wishes not known views sought
  from nominated representative or person in
  qualifying relationship

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Non heart beating donation

• In all cases steps should be taken to ascertain
  an individuals wishes. If this cannot be
  established, it is good practice to gain consent
  before preservation.
• If consent cannot be obtained it is legal to
  undertake minimum steps to preserve organs in
  situation of NHBD whilst awaiting consent
• If consent is not subsequently given all
  procedures to preserve the body must be stopped.

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What will be the impact on organ donation and
transplantation?2. Living donation
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Living donation proportionate regulation

• Non-directed altruistic organ donation
• Directed paired / pooled organ donation
• Non-directed domino organ donation
• Directed genetically or emotionally related
  donor

Risk
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Independent Assessor

• Dual role
• Act on behalf of HTA
• Act as advocate for donor
• Trained and accredited by HTA
• Local recommendation for approval by HTA for
  straightforward directed donation
• Referral to HTA panel for complex cases e.g.
  where donor is child or adult without capacity
  paired and altruistic donation
• Domino and HSC donation excluded

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IA process of assessment and approval

1. Written referral from clinician responsible for
   the donor
2. IA checks necessary information received before
   arranging interview
3. IA sees donor and recipient separately and
   together and ensures requirements of HT Act are
   met
4. Produces written report
5. Local recommendation for approval by HTA or
   approval by HTA panel

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Paired and non-directed altruistic donation

• HTA will be responsible for regulation UK
  Transplant will be responsible for managing the
  process
• Similar referral and assessment process, although
  altruistic donor will also need psychiatric
  assessment
• Referral to HTA panel for approval or otherwise

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Timetable

• Training and accreditation of IAs
• Human Tissue Act implemented
• Transition period

• February to July 2006
• 1 September 2006
• 1 September 2006 for 1 2 months

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What will be the impact on organ donation and
transplantation?3. The Transplant Community
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Impact is planned to be positive

• Opportunities presented by HT Act
• Transplantation Working Group
• Communication and consultation
• Working in partnership with UK Transplant and the
  transplant community
• Smooth transition
• Availability of advice and guidance e.g. Codes of
  Practice

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Any questions?
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www.hta.gov.uk